Alex­ion is re­or­ga­niz­ing R&D, ax­ing 600-plus jobs and mov­ing HQ to Boston as ex­ecs prep deal spree

The new crew in charge of Alex­ion $ALXN is pulling up stakes from New Haven, CT and mov­ing its head­quar­ters to the big bio­phar­ma hub in Boston/Cam­bridge. And the dra­mat­ic move will come with some big lay­offs.

In a top-to-bot­tom re­vamp, Alex­ion CEO Lud­wig Hantson an­nounced plans to down­size R&D as it re­or­ga­nized the pipeline. The bio­phar­ma com­pa­ny al­so plans to shut­ter a va­ri­ety of fa­cil­i­ties, in­clud­ing the Alex­ion Rhode Is­land man­u­fac­tur­ing fa­cil­i­ty and “cer­tain re­gion­al and coun­try-based of­fices.” And it will spend up to $440 mil­lion in a shake­up that in­cludes lay­offs in the com­mer­cial group as well as ad­min­is­tra­tive of­fices as it moves 400 jobs to Boston.

Alex­ion’s HQ is head­ed for a new of­fice build­ing un­der con­struc­tion on the South Boston wa­ter­front, where it’s tak­ing 150,000 square feet. And the Boston Busi­ness Jour­nal re­ports that it will shut­ter a lo­ca­tion it has in Lex­ing­ton, ac­quired in the $8.4 bil­lion Synage­va buy­out — now large­ly writ­ten off as a bust of epic pro­por­tions.

Paul Clan­cy

In a call with an­a­lysts Tues­day morn­ing, the CEO out­lined plans to lay off 20% of its work­force, which would ac­count for more than 600 staffers out of the 3,121 em­ployed at the com­pa­ny at the end of 2016. The re­struc­tur­ing is de­signed to free up $250 mil­lion in an­nu­al spend­ing, $100 mil­lion of which will be steered to new busi­ness de­vel­op­ment deals — an ar­ray of planned li­cens­ing pacts, part­ner­ships and bolt-on ac­qui­si­tions — as well as new tri­als for ‘1210 and oth­er ex­per­i­men­tal ther­a­pies.

“It’s core for the strat­e­gy to re­build the pipeline,” not­ed CFO Paul Clan­cy, who joined Alex­ion from Bio­gen two months ago. So you can look for­ward to a new stream of deals, most fo­cused on Phase I and Phase II as­sets ahead of proof-of-con­cept da­ta.

Alex­ion’s shares slid 1% in ear­ly trad­ing trad­ing.

Alex­ion is mov­ing fast, plan­ning to re­lo­cate 400 po­si­tions by mid-2018, while leav­ing 450 jobs in New Haven. It’s all part of a three-prong strat­e­gy that in­volves big changes in R&D, a new struc­ture for fa­cil­i­ties with more out­sourc­ing on man­u­fac­tur­ing — all play­ing out over the next 12 months.

“By stream­lin­ing our op­er­a­tions we will cre­ate a lean­er or­ga­ni­za­tion with greater fi­nan­cial flex­i­bil­i­ty that is high­ly fo­cused on de­liv­er­ing for pa­tients, grow­ing our rare dis­ease busi­ness, and both lever­ag­ing our lead­er­ship in com­ple­ment and pur­su­ing dis­ci­plined busi­ness de­vel­op­ment to ex­pand the pipeline,” said Hantson. “These types of changes are dif­fi­cult and we rec­og­nize that they have a per­son­al im­pact on peo­ple who have been ded­i­cat­ed to the mis­sion of Alex­ion.”

Hantson took over as CEO at Alex­ion af­ter a probe in the com­pa­ny’s mar­ket­ing prac­tices led to the quick ex­it of two top ex­ecs. He fol­lowed up by re­vamp­ing the ex­ec­u­tive team and an­nounc­ing a pipeline do-over, drop­ping ALXN1101 (cPMP re­place­ment ther­a­py) and ALXN6000 (samal­izum­ab), look­ing for buy­ers to pick these ther­a­pies up. The biotech al­so punt­ed an am­bi­tious ef­fort on a range of pre­clin­i­cal pacts with Mod­er­na, Blue­print and Ar­bu­tus.

Alex­ion faces a se­ri­ous chal­lenge, re­ly­ing for the bulk of its rev­enue on Soliris, one of the world’s most ex­pen­sive ther­a­pies, with a weak pipeline to back it up in of­fer­ing new drugs when its patents start to ex­pire.

In the makeover at Alex­ion, Hantson ev­i­dent­ly wants to re­turn to Boston/Cam­bridge, where he based the spin­off Bax­al­ta be­fore Shire bought it out.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.